CurrentCignaPolicy N/A

Skyrizi Subcutaneous Drug Quantity Management Policy -Per Days

Defines quantity limits, one-time overrides, and coverage criteria for Skyrizi subcutaneous formulations for Cigna-administered health benefit plans; affects providers prescribing or dispensing Skyrizi and pharmacy benefit adjudication.

Policy Summary

PayerCigna

PolicySkyrizi Subcutaneous Drug Quantity Management Policy -Per Days

Policy CodePolicy N/A

Change TypeQuantity limit addedoverride clarificationsrevised override amounts

Effective DateN/A

Next Review DateN/A

Key ActionApprove a one-time 300 mg override for patients initiating plaque psoriasis or psoriatic arthritis with no Skyrizi claims in past 130 days; approval quantity equals prior 84-day mg plus 300 mg.

SourceLink

POLICY UPDATE CHANGES

A new quantity limit was added for one 180 mg/1.2 mL prefilled cartridge per 56 days.

Policy statement was updated to clarify that 'One-time' overrides are provided for 30 days.

Override criteria for 150 mg pens/syringes were updated to express the override amount in mg and added a note that approval quantity equals prior 84-day mg plus 300 mg.

150 mg/84d150 mg syringe limit

1 × 180 mg/56d180 mg cartridge limit

1 × 360 mg/56d360 mg cartridge limit

300 mgOne-time override amount

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Coverage Criteria

Drug quantity limits and overrides

Skyrizi subcutaneous products are covered as medically necessary when quantity limits are met; overrides considered per criteria below.

150 mg prefilled syringe/pen quantity limit: Limit = 150 mg (1 syringe) per 84 days for retail and home delivery; covered when this limit is not exceeded.150 mg per 84 days

See initiation override rules below for plaque psoriasis/psoriatic arthritis.

One-time override for 150 mg pens/syringes: If the patient is initiating treatment for plaque psoriasis or psoriatic arthritis or requires additional induction dosing for these indications, and there are no claims for Skyrizi in the past 130 days, approve a one-time override for 300 mg (2 pens or syringes) at retail or home delivery.no claims in past 130 days

The approval quantity equals the mg received in the past 84 days plus 300 mg; overrides provided as specified in criteria.

180 mg/1.2 mL prefilled cartridge quantity limit: Limit = 180 mg (1 prefilled cartridge, 1.2 mL) per 56 days; covered when this limit is not exceeded.180 mg per 56 days

No overrides recommended for this formulation.

360 mg/2.4 mL prefilled cartridge quantity limit: Limit = 360 mg (1 prefilled cartridge, 2.4 mL) per 56 days; covered when this limit is not exceeded.360 mg per 56 days

No overrides recommended for this formulation.

Any quantity exception outside the specified criteria is considered not medically necessary. The Drug Quantity Limits section specifies maximum quantities per formulation (for example, 150 mg (1 syringe) per 84 days for the 150 mg/mL prefilled syringe and cartridge limits for 180 mg and 360 mg per 56 days); exceptions that do not meet the criteria set forth in this policy will not be covered.

Any other exception to the Drug Quantity Management product(s) is considered not medically necessary. Coverage is limited to the quantity limits and criteria described in this policy for Skyrizi subcutaneous formulations; requests that fall outside those limits and the defined one-time override criteria should be denied as not covered.

Coding Guidance

Coding guidancemixed

affected codes

Policy references use of most appropriate codes; specific covered codes not listed in document.

No prior Skyrizi claims threshold

No Skyrizi claims lookback130 days since last Skyrizi claim required to qualify for initiation one-time override

PurposeVerifies patient is initiating therapy or requires additional induction dosing for plaque psoriasis or psoriatic arthritis

Applies toSkyrizi 150 mg prefilled pens and prefilled syringes (retail and home delivery)

Provider Actions & Billing Rules

Billing Rule

Drug quantity limit and one-time override

Drug Quantity Limits apply at both retail and home delivery by formulation. Maximum quantities per interval: 150 mg (1 syringe) per 84 days for 150 mg/mL prefilled syringe; 180 mg/1.2 mL (1.2 mL = 150 mg/mL) prefilled cartridge — 1.2 mL per 56 days; 360 mg/2.4 mL (150 mg/mL) prefilled cartridge — 2.4 mL per 56 days. For 150 mg/mL prefilled pen the standard maximum quantity aligns with the 150 mg per 84 days formulation.

Applies to retail and home delivery per formulation
See Criteria for one-time override rules

Note

Operational intent

The Drug Quantity Management program manages potential premature dose escalation. If the Drug Quantity Management rule is not met at the point of service, coverage will be determined by the Criteria below. One-time overrides are available and provided for 30 days; operational intent is to permit limited exceptions while protecting against inappropriate early refill or dose increases.

Background

Skyrizi (risankizumab-rzaa) is an interleukin-23 (IL-23) blocker with labeled indications that include plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. For subcutaneous maintenance in plaque psoriasis and psoriatic arthritis the common regimen is 150 mg subcutaneously at Week 0, Week 4, then every 12 weeks; the Drug Quantity Management policy applies to Skyrizi subcutaneous products and sets formulation-specific maximum quantities and any allowable one-time overrides.

Definitions & Dosing Summary

Skyrizi dosing and indications (per prescribing information)

Indications (selected)Crohn's disease; Plaque psoriasis; Psoriatic arthritis; Ulcerative colitis

Plaque psoriasis / Psoriatic arthritis dosing150 mg SC at Week 0, Week 4, then every 12 weeks for maintenance

Crohn's disease / Ulcerative colitis dosingIV induction (Crohn's 600 mg; UC 1,200 mg) at Weeks 0, 4, 8, then SC maintenance 180 mg or 360 mg at Week 12 and every 8 weeks

Formulations referenced150 mg/mL prefilled syringe, 150 mg/mL prefilled pen, 180 mg/1.2 mL prefilled cartridge (150 mg/mL), 360 mg/2.4 mL prefilled cartridge (150 mg/mL)

Initiation / Initial Therapy Criteria

Initiation overrides

Induction dosing and one-time override rules relevant to initiation.

Plaque psoriasis or psoriatic arthritis initiation override: If initiating treatment for plaque psoriasis or psoriatic arthritis and there are no claims for Skyrizi in the past 130 days, approve a one-time 300 mg override (equivalent to 2 pens or syringes) for retail or home delivery.

The approval quantity equals the mg the patient has received in the past 84 days plus 300 mg.

Step Therapy / Drug Quantity Management

Step	Program / Rule	Action if rule not met	Override availability / Duration
{"text":"1","status":""},{"text":"Drug Quantity Management program to manage premature dose escalation for Skyrizi subcutaneous formulations","status":""},{"text":"Coverage determined by the coverage criteria; criteria-based review performed per policy (see quantity limits and initiation override rules)","status":""},{"text":"One-time overrides available; provided for 30 days","status":""}
{"text":"1a","status":""},{"text":"150 mg prefilled syringe / pen limit: 150 mg (1 syringe) per 84 days (retail and home delivery)","status":""},{"text":"If limit exceeded at point of service, evaluate against initiation override criteria (e.g., no Skyrizi claims in past 130 days)","status":""},{"text":"One-time 300 mg override may be approved for initiation of plaque psoriasis or psoriatic arthritis when no Skyrizi claims in past 130 days; approval quantity = mg received in past 84 days plus 300 mg; override duration 30 days","status":""}
{"text":"1b","status":""},{"text":"180 mg / 1.2 mL prefilled cartridge limit: 180 mg (1 prefilled cartridge) per 56 days","status":""},{"text":"If limit exceeded, coverage determined by criteria; no overrides recommended","status":""},{"text":"No overrides recommended (policy added new 180 mg per 56 days limit)","status":""}
{"text":"1c","status":""},{"text":"360 mg / 2.4 mL prefilled cartridge limit: 360 mg (1 prefilled cartridge) per 56 days","status":""},{"text":"If limit exceeded, coverage determined by criteria; no overrides recommended","status":""},{"text":"No overrides recommended","status":""}

Quantity Limits by Formulation

Skyrizi 150 mg/mL prefilled syringe

Strength & form150 mg/mL prefilled syringe

Pack quantity / dose150 mg (1 syringe)

Maximum quantity per policy150 mg (1 syringe) per 84 days (retail and home delivery)

Skyrizi 180 mg/1.2 mL prefilled cartridge

Strength & form180 mg / 1.2 mL (150 mg/mL) prefilled cartridge

Pack quantity / dose180 mg (1 prefilled cartridge, 1.2 mL)

Maximum quantity per policy1 × 180 mg (1.2 mL) per 56 days; new quantity limit added